Original Title: Indicaciones del uso apropiado del marcapasos sin cable. Revisión sistemática y criterios de uso

Authors' objectives: Develop appropriate use criteria for the implantation of VR leadless pacemakers in patients with atrial fibrillation or in sinus rhythm, based on systematic review of the literature and expert panel opinion.

Authors' results and conclusions: Results In the systematic review, no studies were located since 2017 that evaluated the clinical effectiveness or safety of the leadless pacemaker compared to conventional pacemakers. In the two rounds, 64 indications or clinical scenarios were evaluated for atrial fibrillation and 192 for sinus rhythm. The results obtained in the second round for atrial fibrillation were: of the 64 scenarios evaluated, 65.6 % were classified as adequate (71.4 % in agreement), 23.4 % as uncertain and 11 % as inadequate. In the case of sinus rhythm, of the 192 scenarios 46.9 % were considered adequate (agreement was found in 75.6 % of the scenarios), 31.2 % doubtful and 21.9 % inadequate. The degree of disagreement was lower than in the first round, with only 3 scenarios showing disagreement in the total number of scenarios (1.2%). All variables considered for the composition of the panel scenarios in atrial fibrillation and sinus rhythm showed a statistically significant influence according to the logistic regression model. However, limitation for vascular access through the superior vena cava was the variable with the highest predictive ability. The classification trees created showed a summary of the panel results according to the clinical variables assessed. Conclusions The evidence located in the systematic review does not demonstrate the non-inferiority or superiority of this device over the conventional device, although it seems advantageous over conventional devices in certain clinical situations. The RAND/UCLA consensus method was applied to develop appropriate use criteria for the selection and implantation of VR leadless pacemakers in patients with atrial fibrillation and in sinus rhythm. In general, in cases where there is significant or complete limitation of vascular access through the superior vena cava, leadless pacing is appropriate in both patients in atrial fibrillation and those in sinus rhythm, where the usual alternative is surgical implantation of an epicardial lead. The criteria presented can be considered as a decision aid, to be considered in conjunction with other scientific information and in the context of the individual patient-physician relationship. The recommendations presented do not replace the clinical judgement of the practitioner, which always takes into account the particular needs of each clinical situation. To facilitate consultation of the full results of the panel of experts, a computer application has been designed (available at https://www.aetsa.org/calculadora/ ). Patient preferences regarding treatment are an important aspect to be taken into account and in the future it is likely that a greater body of scientific evidence will be available on health outcomes (mortality, cardiovascular morbidity, risk of infection…) in the short and medium term of leadless versus conventional pacing in different clinical scenarios, facilitating decision making for its indication in both patients in atrial fibrillation and those in sinus rhythm.

Authors' methods: Material and method The RAND/UCLA methodology was used to create the criteria for the appropriate use of VR leadless pacing. For this purpose, an update of a previous report with a review of the literature on the effectiveness and safety of leadless pacing in patients with an indication for ventricular pacing was performed for the purpose of providing it to the experts. A list of indications was then compiled from the literature and consultation with cardiology specialists. Finally, an expert panel of 10 experts in the field was formed to score the suitability of the leadless pacemaker in two rounds of voting. The scores were analysed according to statistical criteria, based on the median score for each scenario and the degree of agreement between panellists. Multinomial logistic regression analyses were performed to determine the degree to which each of the individually analysed variables influenced judgements of appropriateness. The explicit criteria developed were summarised using a classification and regression tree analysis.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/indicaciones-del-uso-apropiado-del-marcapasos-sin-cables-revision-sistematica-y-criterios-de-uso/

Year Published: 2023

URL for published report: https://www.aetsa.org/download/publicaciones/Marcapasos-sin-cables_WEB_NIPO.pdf

Requestor: Spanish Health Ministry

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

DOI: 10.52766/KMLY3802

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: <p>Andalusian Agency for Health Technology Assessment (AETSA)</p>